Apparatus for guide-wire based advancement of a rotation assembly

ABSTRACT

Apparatus is provided for use with at least one tissue-adjustment device, including a tissue-engaging element having a distal portion configured to engage at least a first portion of tissue of a patient, and having a proximal portion. At least one docking station is coupled to the proximal portion of the tissue-engaging element and is configured to be coupled to the at least one tissue-adjustment device. The docking station includes a locking mechanism configured to lock the tissue-adjustment device to the tissue-engaging element. At least one guide member is reversibly coupled to the at least one docking station and is configured for facilitating slidable advancement of the at least one tissue-adjustment device toward the tissue-engaging element. Other applications are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is:

(a) a continuation-in-part of U.S. patent application Ser. No.12/608,316 to Miller et al., entitled, “Tissue anchor for annuloplastydevice,” filed on Oct. 29, 2009; and

(b) is related to a US regular application to Miller et al., entitled,“A method for guide-wire based advancement of a rotation assembly,”filed on even date herewith, which is assigned to the assignee of thepresent patent application.

Both of these applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve and chordeae tendineaerepair. More specifically, the present invention relates to repair of anatrioventricular valve and associated chordeae tendineae of a patient.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

Chronic or acute left ventricular dilatation can lead to papillarymuscle displacement with increased leaflet tethering due to tension onchordae tendineae, as well as annular dilatation.

U.S. Pat. No. 7,431,692 to Zollinger et al., which is incorporatedherein by reference, describes an adjustable support pad for adjustablyholding a tensioning line used to apply tension to a body organ. Theadjustable support pad can include a locking mechanism for preventingslidable movement of the tensioning element in one or both directions.The locking mechanism may include spring-loaded locks, rotatablecam-like structures, and/or rotatable spool structures. The adjustablesupport pad may be formed from rigid, semi-rigid, and/or flexiblematerials, and may be formed to conform to the outer surface of a bodyorgan. The adjustable support pad can be configured to adjustably holdone or more separate tensioning lines, and to provide for independentadjustment of one or more tensioning lines or groups thereof.

US Patent Application Publication 2007/0118151 to Davidson, which isincorporated herein by reference, describes a method and system toachieve leaflet coaptation in a cardiac valve percutaneously by creationof neochordae to prolapsing valve segments. This technique is especiallyuseful in cases of ruptured chordae, but may be utilized in any segmentof prolapsing leaflet. The technique described herein has the additionaladvantage of being adjustable in the beating heart. This allowstailoring of leaflet coaptation height under various loading conditionsusing image-guidance, such as echocardiography. This offers anadditional distinct advantage over conventional open-surgery placementof artificial chordae. In traditional open surgical valve repair, chordlength must be estimated in the arrested heart and may or may not becorrect once the patient is weaned from cardiopulmonary bypass. Thetechnique described below also allows for placement of multipleartificial chordae, as dictated by the patient's pathophysiology.

U.S. Pat. No. 6,626,930 to Allen et al., which is incorporated herein byreference, describes apparatus and method for the stabilization andfastening of two pieces of tissue. A single device may be used to bothstabilize and fasten the two pieces of tissue, or a separate stabilizingdevice may be used in conjunction with a fastening device. Thestabilizing device may comprise a probe with vacuum ports and/ormechanical clamps disposed at the distal end to approximate the twopieces of tissue. After the pieces of tissue are stabilized, they arefastened together using sutures or clips. One exemplary application of asuture-based fastener comprises a toggle and suture arrangement deployedby a needle, wherein the needle enters the front side of the tissue andexits the blind side. In a second exemplary application, thesuture-based fastener comprises a needle connected to a suture. Theneedle enters the blind side of the tissue and exits the front side. Thesuture is then tied in a knot to secure the pieces of tissue. Oneexample of a clip-based fastener comprises a spring-loaded clip havingtwo arms with tapered distal ends and barbs. The probe includes adeployment mechanism which causes the clip to pierce and lockinglysecure the two pieces of tissue.

U.S. Pat. No. 6,629,534 to St. Goar et al., which is incorporated hereinby reference, describes methods, devices, and systems are provided forperforming endovascular repair of atrioventricular and other cardiacvalves in the heart. Regurgitation of an atrioventricular valve,particularly a mitral valve, can be repaired by modifying a tissuestructure selected from the valve leaflets, the valve annulus, the valvechordae, and the papillary muscles. These structures may be modified bysuturing, stapling, snaring, or shortening, using interventional toolswhich are introduced to a heart chamber. Preferably, the tissuestructures will be temporarily modified prior to permanent modification.For example, opposed valve leaflets may be temporarily grasped and heldinto position prior to permanent attachment.

U.S. Pat. No. 6,752,813 to Goldfarb et al., which is incorporated hereinby reference, describes methods and devices for grasping, and optionalrepositioning and fixation of the valve leaflets to treat cardiac valveregurgitation, particularly mitral valve regurgitation. Such graspingwill typically be atraumatic providing a number of benefits. Forexample, atraumatic grasping may allow repositioning of the devicesrelative to the leaflets and repositioning of the leaflets themselveswithout damage to the leaflets. However, in some cases it may benecessary or desired to include grasping which pierces or otherwisepermanently affects the leaflets. In some of these cases, the graspingstep includes fixation.

US Patent Application Publication 2003/0105519 to Fasol et al., which isincorporated herein by reference, describes artificial chordae having astrand member and a first and second pair of sutures at eitherlongitudinal end of the strand member. The artificial chordae ispreferably a unitary unit, formed from inelastic flexible material. Inone application, the artificial chordae comprises multiple strandmembers joined together at a joined end. Different sized artificialchordae are provided sized to fit the patient's heart. The appropriatelysized artificial chordae is chosen by using a chordae sizing gaugehaving a shaft and a transverse member, to measure the space within thepatient's heart where the artificial chordae is attached.

The following patents and patent application publications may be ofinterest:

-   PCT Publication WO 06/097931 to Gross et al.-   PCT Publication WO 07/136,783 to Cartledge et al.-   PCT Publication WO 10/004,546 to Gross et al.-   U.S. Pat. No. 5,306,296 to Wright et al.-   U.S. Pat. No. 6,569,198 to Wilson et al.-   U.S. Pat. No. 6,619,291 to Hlavka et al.-   U.S. Pat. No. 6,764,510 to Vidlund et al.-   U.S. Pat. No. 7,004,176 to Lau-   U.S. Pat. No. 7,101,395 to Tremulis et al.-   U.S. Pat. No. 7,175,660 to Cartledge et al.-   US Patent Application Publication 2003/0050693 to Quijano et al-   US Patent Application Publication 2003/0167062 to Gambale et al.-   US Patent Application Publication 2004/0024451 to Johnson et al.-   US Patent Application Publication 2004/0148021 to Cartledge et al.-   US Patent Application Publication 2004/0236419 to Milo-   US Patent Application Publication 2005/0171601 to Cosgrove et al.-   US Patent Application Publication 2005/0216039 to Lederman-   US Patent Application Publication 2005/0288781 to Moaddeb et al.-   US Patent Application Publication 2007/0016287 to Cartledge et al.-   US Patent Application Publication 2007/0080188 to Spence et al.-   US Patent Application Publication 2008/0262609 to Gross et al.-   US Patent Application Publication 2009/0177266 to Powell et al.

SUMMARY OF THE INVENTION

In some applications of the present invention, apparatus is providedcomprising one or more primary adjustable repair chords and anadjustment mechanism that is configured to adjust a tension of the oneor more adjustable repair chords and that is slidable along a guide wiretoward an implantation site. Additionally, the apparatus comprises afirst tissue-engaging element (e.g., a tissue anchor) that comprises oneor more docking stations. A respective guide wire is reversibly coupledto each one of the docking stations. The adjustment mechanism isslidable along the guide wire toward one of the one or more dockingstations, and is coupled to the tissue-engaging element via the dockingstation. Thus, the docking station is a coupling element that providescoupling between two other elements (in this case, between adjustmentmechanism and the tissue-engaging element.) The repair chord comprises aflexible, longitudinal member (e.g., sutures or wires). The repair chordis coupled at a distal portion thereof to the adjustment mechanism. Insome applications, the repair chord functions as artificial chordaetendineae. In other applications, the repair chord is used to adjust adistance between two portions of the ventricular wall. For someapplications, the repair chord is coupled at a proximal portion thereofto a second tissue-engaging element.

Typically, during a transcatheter procedure, the first tissue-engagingelement is coupled to a first portion of tissue at a first implantationsite in a heart of a patient. The adjustment mechanism is then slidalong the guide wire and toward the first tissue-engaging element at thefirst implantation site. The proximal portion of the repair chord isthen coupled via the second tissue-engaging element to a second portionof tissue at a second implantation site. Following the coupling of thesecond tissue-engaging element to the second implantation site, theadjustment mechanism is further slid distally toward the firsttissue-engaging element and is then coupled to the first tissue-engagingelement via the one or more docking stations on the firsttissue-engaging element. Following the coupling of the adjustmentmechanism to the second tissue-engaging element, a length and tension ofthe repair chord is then adjusted in order to adjust a distance betweenthe first and second implantation sites. For applications in which therepair chord functions as an artificial chordea tendinea, the adjustmentof the length and tension of the repair chord draws the leafletstogether, and/or pulls the leaflet down toward the first implantationsite.

In some applications of the present invention, the adjustment mechanismcomprises a spool assembly which adjusts a degree of tension of therepair chord. The spool assembly comprises a housing, which houses aspool to which a distal portion of the repair chord is coupled.

For applications in which the repair chord is coupled to two respectiveportions of the ventricular wall, the two portions are drawn together,thereby restoring the dimensions of the heart wall to physiologicaldimensions, and drawing the leaflets toward one another.

In some applications of the present invention, the adjustment mechanismcomprises a reversible locking mechanism which facilitates bidirectionalrotation of the spool in order to effect both tensioning and relaxing ofthe repair chord. That is, the spool is wound in one direction in orderto tighten the repair chord, and in an opposite direction in order toslacken the repair chord. Thus, the spool adjustment mechanismfacilitates bidirectional adjustment of the repair chord.

In some applications of the present invention, the adjustable repairchord is implanted during an open-heart procedure. In theseapplications, the delivery tool comprises a handle and a multilumenshaft that is coupled at a distal end thereof to the adjustmentmechanism. The delivery tool functions to advance the adjustmentmechanism to the first portion of tissue, implant the adjustmentmechanism at the first portion of tissue, and effect adjustment of therepair chord by effecting rotation of the spool. For applications inwhich the repair chord functions as an artificial chordea tendinea,prior to implantation of the adjustment mechanism, the distal portion ofthe delivery tool and the adjustment mechanism coupled thereto areadvanced between the leaflets of the atrioventricular valve and into theventricle toward the first portion of tissue. The incision made in theheart is then closed around the delivery tool and the heart resumes itsnormal function during the adjustment of the length of the artificialchordea tendinea.

In some applications of the present invention, apparatus and methoddescribed herein may be used for providing artificial chordae tendineaein a left ventricle of the heart and effecting adjustment thereof. Insome applications, apparatus and method described herein may be used forproviding artificial chordae tendineae in a right ventricle of the heartand effecting adjustment thereof. In some applications, apparatus andmethod described herein may be used for providing a system to adjust alength between two portions of the heart wall.

There is therefore provided, in accordance with some applications of thepresent invention apparatus for use with at least one tissue-adjustmentdevice, including:

a tissue-engaging element having a distal portion configured to engageat least a first portion of tissue of a patient, and having a proximalportion;

at least one docking station coupled to the proximal portion of thetissue-engaging element, the at least one docking station:

-   -   being configured to be coupled to the at least one        tissue-adjustment device, and    -   including a locking mechanism configured to lock the        tissue-adjustment device to the tissue-engaging element; and

at least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one tissue-adjustment device towardthe tissue-engaging element.

In some applications of the present invention, the guide member islooped around a portion of the docking station.

In some applications of the present invention, the at least one dockingstation includes two or more docking stations, and the at least oneguide member includes two or more guide members, each guide member beingreversibly coupled to a respective docking station.

In some applications of the present invention, the apparatus includesthe tissue-adjustment device, the tissue-adjustment device has:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second opening, the        channel facilitating advancement of the tissue-adjustment device        along the guide member.

In some applications of the present invention, the tissue-adjustmentdevice includes a first coupling, and the locking mechanism includes asecond coupling configured to be coupled to the first coupling.

In some applications of the present invention, the second couplingincludes at least one depressed portion, and the first coupling includesat least one moveable baffle which is configured to engage the at leastone depressed portion of the second coupling.

In some applications of the present invention, the apparatus includes atleast one flexible longitudinal member coupled at a first portionthereof to the tissue-adjustment device, a second portion of theflexible longitudinal member is configured to be coupled to a secondportion of tissue of the patient, and the tissue-adjustment device isconfigured to adjust a length of the longitudinal member between thefirst and second portions of tissue.

In some applications of the present invention:

the first portion of tissue includes a first portion of cardiac tissueat a first intraventricular site,

the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and

the flexible longitudinal member includes at least one artificialchordea tendinea.

In some applications of the present invention:

the tissue-adjustment device includes a rotatable structure,

the at least one flexible longitudinal member is coupled at the firstportion to the rotatable structure, and

the rotatable structure is bidirectionally rotatable to adjust thedegree of tension of the at least one flexible longitudinal member.

In some applications of the present invention, during rotation of therotatable structure in a first rotational direction, successive portionsof the flexible longitudinal member advance in a first advancementdirection with respect to the rotatable structure and contact therotatable structure, to pull the second portion of the flexible membertoward the tissue-adjustment device, and to draw the first and secondportions of tissue toward each other.

In some applications of the present invention, the apparatus includes arotatable structure locking mechanism displaceable with respect to therotatable structure, so as to:

release the rotatable structure during rotation of the rotatablestructure, and

lock in place the rotatable structure following rotation of therotatable structure.

In some applications of the present invention, the rotatable structureincludes a spool, and the at least one flexible longitudinal member isconfigured to be wound around the spool during the rotation of the spoolin a first rotational direction thereof.

In some applications of the present invention, the first portion of theat least one flexible longitudinal member is looped through a portion ofthe spool.

In some applications of the present invention, the first portion of theat least one flexible longitudinal member is wound around a portion ofthe spool, and the first portion of the at least one flexiblelongitudinal member is configured to be unwound from around the portionof the spool following the coupling of the second portion of theflexible longitudinal member to the second portion of tissue of thepatient.

There is also provided, in accordance with some applications of thepresent invention, apparatus, including:

a tissue-engaging element having a distal portion configured to engageat least a first portion of tissue of a patient, and having a proximalportion;

at least one docking station coupled to the proximal portion of thetissue-engaging element;

a tissue-adjustment device couplable to the at least one dockingstation, the tissue-adjustment device comprising:

-   -   a rotatable structure; and    -   at least one flexible longitudinal member having a first portion        thereof that is in contact with the rotatable structure, and a        second portion thereof that is configured to be coupled to a        second portion of tissue of the patient,    -   wherein in during rotation of the rotatable structure in a first        rotational direction, successive portions of the flexible        longitudinal member advance in a first advancement direction        with respect to the rotatable structure and contact the        rotatable structure, and, pull the second portion of the        flexible longitudinal member toward the tissue-adjustment        device, and responsively, to draw the first and second portions        of tissue toward each other; and

at least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one tissue-adjustment device towardthe tissue-engaging element.

In some applications of the present invention, the guide member islooped around a portion of the docking station.

In some applications of the present invention, the at least one dockingstation includes two or more docking stations, and the at least oneguide member includes two or more guide members, each guide member beingreversibly coupled to a respective docking station.

In some applications of the present invention, the tissue-adjustmentdevice has:

-   -   an upper surface and a lower surface,    -   at least one first opening at the upper surface,    -   at least one second opening at the lower surface, and    -   a channel extending between the first and second opening, the        channel facilitating advancement of the tissue-adjustment device        along the guide member.

In some applications of the present invention, the tissue-adjustmentdevice includes a first coupling, and the docking station includes asecond coupling configured to be coupled to the first coupling.

In some applications of the present invention, the second couplingincludes at least one depressed portion, and the first coupling includesat least one moveable baffle which is configured to engage the at leastone depressed portion of the second coupling.

In some applications of the present invention, the second couplingincludes a locking mechanism configured to lock the tissue-adjustmentdevice to the tissue-engaging element.

In some applications of the present invention:

the first portion of tissue includes a first portion of cardiac tissueat a first intraventricular site,

the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and

the flexible longitudinal member includes at least one artificialchordea tendinea.

In some applications of the present invention, the rotatable structureis rotatable in a first rotational direction to apply tension to theflexible longitudinal member, and in a second rotational direction thatis opposite the first rotational direction to slacken the flexiblelongitudinal member.

In some applications of the present invention, during rotation of therotatable structure in a first rotational direction thereof, successiveportions of the flexible longitudinal member advance in a firstadvancement direction with respect to the rotatable structure andcontact the rotatable structure, responsively, to pull the secondportion of the flexible longitudinal member toward the tissue-adjustmentdevice.

In some applications of the present invention, the apparatus includes arotatable structure locking mechanism, displaceable with respect to therotatable structure so as to:

release the rotatable structure during rotation of the rotatablestructure, and

lock in place the rotatable structure following rotation of therotatable structure.

In some applications of the present invention, the rotatable structureincludes a spool, and the at least one flexible longitudinal member isconfigured to be wound around the spool during the rotation of the spoolin the first rotational direction thereof.

In some applications of the present invention, the first portion of theflexible longitudinal member is looped through a portion of the spool.

In some applications of the present invention, the first portion of theflexible longitudinal member is wound around a portion of the spool, andthe first portion of the flexible longitudinal member is configured tobe unwound from around the portion of the spool following the couplingof the second portion of the flexible longitudinal member to the secondportion of tissue of the patient.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-2 are schematic illustrations of apparatus comprising atissue-engaging element comprising a docking station coupled to a guidewire, in accordance with some applications of the present invention;

FIG. 3 is a schematic illustration of advancement of an adjustmentmechanism along the guide wire toward the docking station of FIGS. 1 and2, in accordance with some applications of the present invention;

FIGS. 4-5 are schematic illustrations of engaging a leaflet with aleaflet engaging element, in accordance with some applications of thepresent invention;

FIG. 6 is a schematic illustration of coupling of the adjustmentmechanism of FIG. 3 to the docking station, in accordance with someapplications of the present invention;

FIGS. 7-9 are schematic illustrations of adjusting by the adjustmentmechanism a length of a repair chord coupled to the adjustmentmechanism, in accordance with some applications of the presentinvention;

FIG. 10 is a schematic illustration of the adjustment mechanism and therepair chord, in accordance with some other applications of the presentinvention;

FIGS. 11-15 are schematic illustrations of a plurality of dockingstations and a plurality of adjustment mechanisms, in accordance withsome applications of the present invention;

FIG. 16 is a schematic illustration of wall-to-wall adjustment using thedocking station, adjustment mechanism, and repair chord, in accordancewith some applications of the present invention;

FIG. 17 is a schematic illustration of wall-to-wall adjustment andleaflet adjustment using the plurality of docking stations, theplurality of adjustment mechanisms, and the plurality of repair chords,in accordance with some applications of the present invention;

FIG. 18 is a schematic illustration of wall-to-wall adjustment using thedocking station, adjustment mechanism, and repair chord, in accordancewith some other applications of the present invention; and

FIGS. 19-20 are schematic illustrations of adjustment of a valve of apatient from a middle portion of the valve, in accordance with someapplications of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa system 20 comprising a docking assembly 150 for implantation at afirst implantation site 5 of a patient, in accordance with someapplications of the present invention. Docking assembly 150 comprises adistal tissue anchor 50 (e.g., a helical tissue anchor as shown by wayof illustration and not limitation), a docking platform 54, and at leastone docking station 56, as shown in FIG. 2. At least one guide member,(e.g., a guide wire 40) is reversibly coupled to docking assembly 150(e.g., by being looped around a portion of assembly 150) so as to definefirst and second portions 40 a and 40 a′ that extend away from assembly150.

Tissue anchor 50 is implanted within cardiac tissue in a manner in whicha distal portion of anchor 50 does not extend beyond an epicardium ofheart 2 of the patient. Thus, anchor 50 is implanted at an intracardiacsite such that the adjustment mechanism that is eventually coupledthereto (as described hereinbelow) is implanted at the intracardiac sitesuch that no portions of the adjustment mechanism extend beyond theepicardium of the heart.

Docking assembly 150 and guide wire 40 are advanced toward implantationsite typically during a transcatheter procedure, as shown. However, itis to be noted that the scope of the present invention includes theadvancement of assembly 150 and guide wire 40 during aminimally-invasive or open-heart procedure. The procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography.

The procedure typically begins with the advancing of a semi-rigid guidewire into a right atrium of the patient. The semi-rigid guide wireprovides a guide for the subsequent advancement of a sheath 28therealong and into the right atrium. Once sheath 28 has entered theright atrium, the semi-rigid guide wire is retracted from the patient'sbody. Sheath 28 typically comprises a 13-20 F sheath, although the sizemay be selected as appropriate for a given patient. Sheath 28 isadvanced through vasculature into the right atrium using a suitablepoint of origin typically determined for a given patient. For example:

-   -   sheath 28 may be introduced into the femoral vein of the        patient, through an inferior vena cava, into the right atrium,        and into the left atrium transseptally, typically through the        fossa ovalis;    -   sheath 28 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into the right        atrium, and into the left atrium transseptally, typically        through the fossa ovalis; or    -   sheath 28 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into the        right atrium, and into the left atrium transseptally, typically        through the fossa ovalis.

In some applications of the present invention, sheath 28 is advancedthrough the inferior vena cava of the patient (as shown) and into theright atrium using a suitable point of origin typically determined for agiven patient.

Sheath 28 is advanced distally until the sheath reaches the interatrialseptum. For some applications, a resilient needle and a dilator (notshown) are advanced through sheath 28 and into the heart. In order toadvance sheath 28 transseptally into the left atrium, the dilator isadvanced to the septum, and the needle is pushed from within the dilatorand is allowed to puncture the septum to create an opening thatfacilitates passage of the dilator and subsequently sheath 28therethrough and into the left atrium. The dilator is passed through thehole in the septum created by the needle. Typically, the dilator isshaped to define a hollow shaft for passage along the needle, and thehollow shaft is shaped to define a tapered distal end. This tapereddistal end is first advanced through the hole created by the needle. Thehole is enlarged when the gradually increasing diameter of the distalend of the dilator is pushed through the hole in the septum.

The advancement of sheath 28 through the septum and into the left atriumis followed by the extraction of the dilator and the needle from withinsheath 28. Subsequently, a docking-assembly delivery tool 30 is advancedthrough sheath 28. Tool 30 is typically advanced within a lumen of anadvancement sheath 22 having a distal end 24. Advancement sheath 22 isadvanced within sheath 28. Delivery tool 30 is coupled at a distal endthereof to a manipulator 32 which is reversibly coupled to dockingstation 56 and docking platform 54 of docking assembly 150. Manipulator32 has lateral arms which cup platform 54, and manipulator has adocking-station-coupler 34, as shown in FIG. 1. Coupler 34 is biased tomove radially-inward, as shown in FIG. 1. Docking station 56 is ribbed,such that coupler 34, when moved radially inward, engages at least onerib of docking station 56, thereby coupling assembly 150 to deliverytool 30.

Docking assembly 150 is implanted in implantation site 5 when tool 30 isrotated to rotate anchor 50 and corkscrew anchor 50 into tissue of site5. Site 5 typically comprises a portion of tissue at an intraventricularsite in heart 2 of the patient. As shown, site 5 includes a papillarymuscle 4, by way of illustration and not limitation. It is to be notedthat site 5 includes any portion of cardiac tissue, e.g., a portion of afree wall of the ventricle, a portion of the septum facing theventricle, a portion of tissue at a base of the papillary muscle, or aportion of the wall at the apex of the ventricle. (For the purposes ofthe claims, “a portion of tissue of a ventricle” includes any portion ofcardiac tissue, e.g., a portion of a free wall of the ventricle, aportion of the septum facing the ventricle, a portion of tissue at abase of the papillary muscle, or a portion of the wall at the apex ofthe ventricle.)

Following the implantation of assembly 150 at site 5, tool 30 isdisengaged from assembly 150 when the physician pulls on tool 30. Thispulling pulls on manipulator 32 such that coupler 34 is actively movedradially outward against the ribs of docking station 56, and is therebydecoupled from station 56. At the time of pulling, tissue atimplantation site 5 pulls on assembly 150 so as to help disengage tool30 from assembly 150.

As shown in FIG. 2, following the decoupling of tool 30 from assembly150, tool 30 is pulled proximally along guide wire 40 and is extractedfrom the body of the patient together with advancement sheath 22,leaving behind assembly 150 and guide wire 40.

FIG. 3 shows advancement of a spool assembly 36 comprising an adjustmentmechanism 43, along guide wire 40 by an adjustment-mechanism deliverytool 64, in accordance with some applications of the present invention.Tool 64 is surrounded by and slidable within an advancement sheath 60having a distal end 62. Spool assembly 36 is surrounded by a braidedfabric mesh, e.g., a polyester mesh, which promotes fibrosis aroundassembly 36 and facilitates coupling of assembly 36 to tissue of heart2. Assembly 36 houses a rotatable structure (e.g., a spool as shownhereinbelow) that is surrounded by a housing 49. Housing 49 is coupledto a distal cap 44 which facilitates coupling of assembly 36 to dockingstation 56 of docking assembly 150. As shown, cap 44 is shaped so as todefine a plurality of baffles 47 that are disposed angularly withrespect to a distal end of cap 44, and are coupled to the distal end ofcap 44 along a coupling joint which facilitates slight movement of eachbaffle 47. During the coupling of spool assembly 36 to docking station56, the ribbed portion of docking station 56 pushes inwardly baffles 47of cap 44, as is described hereinbelow. Baffles 47 then expand andengage an area of docking station 56 between the ribs of the ribbedportion so as to dock and lock assembly 36 to docking station 56.

Additionally, cap 44 is shaped so as to define a central openingtherethrough which facilitates passage through the opening of guide wire40. Additionally, spool assembly 36 and the components thereof areshaped so as to define a central opening (i.e., an opening having thesame axis as guide wire 40). That is, spool 46 has a central opening,and housing 49 has a central opening which facilitates passage of spool46 and housing 49 along guide wire 40.

As shown, adjustment mechanism 43 is coupled to a distal portion of arepair chord 74 (e.g., repair chord 74 is looped through a portion ofadjustment mechanism 43). For some applications, and as is describedhereinbelow, chord 74 functions as an artificial chordea tendinea. Aproximal portion of chord 74 is coupled to a leaflet-engaging element 72(e.g., a clip, as shown). Leaflet-engaging element 72 is disposed withina holder 70 that is coupled to delivery tool 64. Chord 74 asuperelastic, biocompatible material (e.g., nitinol, ePTFE, PTFE,polyester, stainless steel, or cobalt chrome). Typically, chord 74comprises an artificial chordea tendinea.

FIGS. 4-5 are schematic illustrations of the engaging ofleaflet-engaging element 72 to at least one leaflet 14 of a mitral valveof the patient, in accordance with some applications of the presentinvention. As shown in FIG. 4, the clip is opened from a remote locationoutside the body of the patient.

For some applications, the clip typically is shaped so as to define atleast one coupling protrusion 73. The clip has a tendency to close, andis initially held open by a cord (not shown) that is coupled to asurface of the clip, extends through delivery tool 64, and is heldtaught outside of the heart. Once the clip has been advanced to thedesired location on the leaflet, the cord is relaxed, allowing the clipto close. The cord is removed, typically by releasing one end thereofand pulling the other end. The positioning of holder 70 between theleaflets (FIG. 5) helps ensure that the clip engages exactly one of theleaflets. It is noted that in FIG. 5 the clip is shown engaging only asingle leaflet (leaflet 14). The clip typically engages the leaflet byclamping the leaflet such that the clip engages atrial and ventricularsurfaces of the leaflet. The clip may puncture the leaflet, or maymerely press firmly against the leaflet.

Holder 70 is shaped to define a groove which houses the clip during theadvancement of tool 64 toward the ventricle. The groove functions as atrack to facilitate slidable detachment of the clip from holder 70following the engaging of the clip to leaflet 14.

Alternatively, the clip has a tendency to open. In order to close theclip, a cord is provided. A distal-most portion of the cord is loopedaround the clip. Once the clip has been advanced to the desired locationon the leaflet, as shown in FIG. 5, the surgeon pulls on both ends ofthe cord, thereby causing the clip to become locked closed. The cord isremoved, typically by releasing one end thereof and pulling the otherend.

It is to be noted that the scope of the present invention includes anyleaflet-engaging element known in the art. In particular techniques foruse of leaflet-engaging element 72 may be practiced in combination withany one of the leaflet-engaging elements as described in U.S. patentapplication Ser. No. 12/548,991 to Maisano et al., entitled,“Implantation of repair chords in the heart,” filed on Aug. 27, 2009,which is incorporated herein by reference.

As shown in FIG. 5, portions 74 a and 74 b extend from leaflet engagingelement 72 toward adjustment mechanism 43. Portions 74 a and 74 b defineportions of a single chord 74 that is looped through a portion ofmechanism 43. Alternatively, portions 74 a and 74 b represent twodistinct chords which are coupled at their distal ends to adjustmentmechanism 43 and at their proximal ends to leaflet-engaging element 72.

As shown, leaflet-engaging element 72 engages leaflet 14 prior tocoupling spool assembly 36 to docking station 56.

FIG. 6 shows spool assembly 36 being coupled to docking station 56, inaccordance with some applications of the present invention. Followingthe coupling of leaflet-engaging element 72 to leaflet 14, spoolassembly 36 is pushed distally toward docking station 56. Spool assembly36 is coupled to an advancement shaft 80 which slides within a lumen ofdelivery tool 64 and within a lumen of holder 70 so as to advance spoolassembly 36 while leaflet-engaging element 72 remains engaged withleaflet 14. Advancement shaft 80 functions to advance distally spoolassembly 36 to facilitate engagement between spool assembly 36 anddocking station 56. As described hereinabove, docking station 56 has oneor more ribs 57 (shown in the enlarged cross-sectional image of FIG. 6)which project laterally such that rib 57 defines a shelf and an areaunderneath the shelf that is depressed. As described hereinabove, cap 44of assembly 36 is shaped so as to define a plurality of baffles 47. Ascap 44 engages docking station 56, baffles 47 are pushed inward andupward angularly as each baffle slides against rib 57. After each baffle47 passes the shelf of rib 57, the baffle engages the depressed portionunderneath rib 57, as shown in the enlarged cross-sectional image ofFIG. 6. The shelf of rib 57 prevents upward movement of baffles 47 andthereby locks in place baffles 47 and cap 44 with respect to dockingstation 56. Rib 57 therefore comprises a locking mechanism to lockadjustment mechanism 43 to tissue anchor 50.

Following the coupling of assembly 36 to docking station 56, spool 46 isrotated in a first direction thereof in order to advance with respect tospool 46 (e.g., loop around spool 46) and contact with spool 46successive portions chord 74. The rotating of spool 46 in the firstdirection thereof pulls tight and adjusts a length of chord 74 betweenleaflet 14 and spool 46, in order to adjust a distance between leaflet14 and implantation site 5, as is described hereinbelow. Housing 49 isshaped so as to provide openings 41 a and 41 b for passage therethroughof portions 74 a and 74 b, respectively, of chord 74 into housing 49.For some applications of the present invention, portions 74 a and 74 bdefine portions of a single chord 74 that is looped through spool 46.For other applications, portions 74 a and 74 b define discrete chordswhich are each coupled at respective distal ends thereof to spool 46.

The enlarged, cross-sectional image of FIG. 6 shows spool 46 withinhousing 49. Spool 46 defines an upper surface 150, a lower surface 152,and a cylindrical body portion disposed vertically between surfaces 150and 152. Spool 46 is shaped to provide a driving interface, e.g., achannel, which extends from an opening provided by upper surface 150 toan opening provided by lower surface 152. A proximal portion of thedriving interface is shaped to define a threaded portion 146 which mayor may not be tapered. Threaded portion 146 of spool 46 is engageable bya threaded portion of a screwdriver head 92 of a screwdriver 90.Rotation of screwdriver head 92 rotates spool 46 as the respectivethreaded portions of spool 46 and screwdriver head 92 engage. Thecylindrical body portion of spool 46 is shaped to define one or moreholes which function as respective coupling sites for coupling (e.g.,looping through the one or more holes, or welding to spool 46 in thevicinity of the one or more holes) of any number of chords 74 to spool46.

Lower surface 152 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions 155 of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,circumferentially or otherwise with respect to lower surface 152 ofspool 46.

As shown, a locking mechanism 45 is disposed in communication with lowersurface 152 of spool 46 and disposed in communication with at least inpart to a lower surface of housing 49. Typically, a cap 44 maintainslocking mechanism 45 in place with respect to lower surface 152 of spool46 and lower surface of housing 49. For some applications, lockingmechanism 45 is coupled, e.g., welded, to the lower surface of housing49. Typically, locking mechanism 45 defines a mechanical element havinga planar surface that defines slits. It is to be noted that the surfaceof locking mechanism 45 may also be curved, and not planar. Lockingmechanism 45 is shaped to provide a protrusion 156 which projects out ofa plane defined by the planar surface of the mechanical element. Theslits of mechanism 45 define a depressible portion 128 that is disposedin communication with and extends toward protrusion 156. Depressibleportion 128 is moveable in response to a force applied thereto typicallyby an elongate locking mechanism release rod 94 which slides through alumen of screwdriver 90 and a torque-delivering tool that is coupledthereto. Techniques for using screwdriver 90 and locking mechanism 45may be practiced in combination with any one of the apparatus andtechniques as described in U.S. Provisional Patent Application61/265,936 to Miller et al., entitled, “Delivery tool for implantationof spool assembly coupled to a helical anchor,” filed Dec. 2, 2009,which is incorporated herein by reference.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

Cap 44 is provided that is shaped to define a planar surface and anannular wall having an upper surface thereof. The upper surface of theannular wall is coupled to, e.g., welded to, a lower surface provided byhousing 49. The annular wall of cap 44 is shaped to define a recessedportion 144 of cap 44 that is in alignment with a recessed portion 142of spool housing 49.

As shown, a distal end 96 of locking mechanism release rod 94 pushesdistally on depressible portion 128 in order to unlock locking mechanism45 from spool 46. Pushing depressible portion 128 by locking mechanismrelease rod 94 pushes distally protrusion 156 within recessed portion142 of housing 49 and within recessed portion 144 of cap 44, which freesprotrusion 156 from recesses 154 of spool 46. Once protrusion 156 isreleased from recesses 154 of spool 46, the physician is able to rotatespool 46 bidirectionally in order to adjust a tension of chord 74.

When the physician rotates spool 46 in the first rotational direction,chord 74 is pulled tight, and leaflet 14 is drawn toward adjustmentmechanism 40 and toward anterior leaflet 12 of mitral valve 8.

In the resting state (i.e., prior to the rotation of spool 46 in orderto adjust chord 74, following coupling of leaflet-engaging element 72 toleaflet 14) chord 74 is wrapped around spool 46 a few times (e.g., threetimes, by way of illustration and not limitation). This winding providesexcess slack to chord 74 (in case portions 74 a and 74 b are coupled tootightly to leaflet 14). If the physician wishes to provide slack tomember 74 or to any one of portion 74 a or 74 b, the physician unwinds abit of the wrapped portion of member 74 from around spool 46 (e.g., byunwinding chord 74 a few times from around spool 46, or by unwindingchord 74 entirely from around spool 46 so that chord 74 slides freelythrough spool 46 within a channel provided therein). In order toaccomplish such unwinding, the physician rotates spool 46 in arotational direction in which it unwinds the wrapped portion of chord74. Since chord 74 is looped through spool 46 in the channel providedtherein, when chord 74 is unwound from spool 46, the physician can pullon one or both portions 74 a and 74 b so as to adjust, make even, orfurther slacken any one of or both portions 74 a and 74 b that extendfrom spool 46.

When the physician desires to pull tight chord 74, he or she effectsrotation of spool 46 in a first rotational direction, i.e., thedirection opposite the second rotational direction in which spool 46 isrotated during the unwinding of chord 74 from spool 46. Rotation ofspool 46 in the first rotational direction winds chord 74 around spool46, while rotation of spool 46 in a second rotational direction oppositethe first rotational direction, unwinds the portion of longitudinalchord 74 from around spool 46.

FIG. 7 shows spool assembly 36 following the adjustment of chord 74 byrotating screwdriver 90 in the direction as indicated by the arrow, andthe partial removal of screwdriver 90, in accordance with someapplications of the present invention. As shown in the enlargedcross-sectional image of FIG. 7, successive portions of chord 74 arewrapped around spool 46. That is, chord 74 is wrapped more times aroundspool 46 following adjustment (e.g., an additional 4 times, as shown inFIG. 7), than prior to adjustment (FIG. 6). This pulls chord 74 from aslackened state (FIG. 6) to a taut state (FIG. 7) in order to adjust alength of chord 74 between adjustment mechanism 43 and the proximal endof chord 74 that is coupled to leaflet-engaging element 72.Additionally, this applying of tension to chord 74 adjusts a lengthbetween first and second implantation sites 5 and 7. Typically, chord 74is adjusted while heart 2 is beating.

As shown, rod 94 is shaped so as to define a central lumen and a distalopening for passage therethrough of guide wire 40. Additionally,depressible portion 128 is shaped so as to provide an opening forpassage of guide wire 40 therethrough. Guide wire 40 is looped around adistal looping element 55 of docking platform 54 of docking assembly150. Following the adjusting of the tension and length of chord 74,screwdriver 90 is decoupled from spool 46 (e.g., by being unscrewed fromthreaded portion 146 of spool 46) and is advanced proximally togetherwith rod 94 away from spool assembly 36, as shown in the enlarged,cross-sectional image of FIG. 7. Guide wire 40 remains coupled todocking platform 54 and docking assembly 150 following removal ofscrewdriver 90. Guide wire 40 then facilitates subsequent advancement ofscrewdriver 90 or any other tool to access spool assembly 36 and/or tofacilitate further adjustment of chord 74 beyond the initial adjustment.Guide wire 40 may remain chronically coupled to docking assembly 150 andaccessible at a subcutaneous location of the patient, e.g., a port. Forother applications, guide wire 40 is removed from docking assembly 150when the physician determines that further adjustment of chord 74 is notneeded. The physician removes guide wire 40 by pulling from outside thebody of the patient, one end of guide wire 40 so that guide wire 40slides around element 55 and is unlooped therefrom. The physiciancontinues to pull on the end of guide wire 40 until the second end isexposed and removed from the patient.

Following the removal of locking-mechanism release rod 94, depressibleportion 128 is no longer depressed by distal end 96 of rod 94, andprotrusion 156 returns within a recess 154 of spool 46 so as to lockspool 46 in place and restriction rotation thereof in either direction.

Reference is now made to FIGS. 3-7. It is to be noted that spoolassembly 36 is only coupled to docking assembly 150 following thecoupling of leaflet-engaging element 72 to leaflet 14. This is done inorder to reduce the strain on implantation site 5. Should spool assembly36 be implanted at implantation site 5 prior to engaging leaflet 14 withleaflet-engaging element 72, more strain would be applied toimplantation site 5 than if spool assembly 36 been implanted followingthe coupling of leaflet-engaging element 72 to leaflet 14, as describedherein.

FIG. 8 shows system 20 following removal of the tool used to rotatespool 46 of spool assembly 36, in accordance with some applications ofthe present invention. As shown, chord 74 is pulled tight such that itslength and tension are adjusted, and leaflet 14 is pulled and adjustedcommensurate with the adjustment of chord 74. Guide wire 40 remainscoupled to spool assembly 36 and to docking assembly 150, as shown, suchthat portions 40 a and 40 a′ extend from spool assembly 36. Guide wire40 facilitates the reintroduction of the tool used to rotate spool 46,or of any other tool.

FIG. 9 shows system 20 following the removal of guide wire 40 from heart2, in accordance with some applications of the present invention. Asshown, the adjustment of chord 74 draws leaflets 12 and 14 together.

FIG. 10 shows a system 220, as described hereinabove, with the exceptionthat implantation site 5 includes tissue of the wall of the ventricle atthe base of papillary muscle 4 in a vicinity of the apex of the heart,in accordance with some applications of the present invention.Implantation site 5 is shown by way of illustration and not limitation,and as described hereinabove, site 5 may include any portion of tissueof heart 2.

FIGS. 11-15 are schematic illustrations of a system 320 comprising amultiple-docking-station assembly 350 comprising a plurality of dockingstations 56, in accordance with some applications of the presentinvention. Multiple-docking-station assembly 350 comprises a tissueanchor 50 and a docking platform 322 which supports two or more dockingstations 56. Platform 322 supports three docking stations 56 a, 56 b,and 56 c, by way of illustration and not limitation. Platform 322 maysupport any number of docking stations 56. As shown, each dockingstation 56 a, 56 b, and 56 c is reversibly coupled to a respective guidewire 40 a, 40 b, and 40 c, in a manner as described hereinabove. Eachdocking station 56 a, 56 b, and 56 c facilitates coupling thereto of arespective spool assembly 36 a, 36 b, and 36 c, or any other tool ordevice which may be coupled to docking stations 56 a, 56 b, and 56 c.

As shown in FIGS. 11-13, first and second spool assemblies 36 a and 36 bare coupled via guide wires 40 a and 40 b to respective docking stations56 a and 56 b. Each spool assembly 36 a and 36 b has a respective chord74 aa and 74 bb extending therefrom. For example, the chord extendingfrom spool assembly 36 a has portions 74 aa and 74 aa′ extending fromspool assembly 36 a. Each chord 74 is coupled to a respectiveleaflet-engaging element 72. That is, chord 74 aa is coupled toleaflet-engaging element 72 a, and chord 74 bb is coupled toleaflet-engaging element 72 b. Each leaflet-engaging element 72 a and 72b is coupled to leaflets 12 and 14, respectively, and each spoolassembly 36 a and 36 b is coupled to respective docking stations 56 aand 56 b, as described hereinabove (FIG. 13). Chords 74 aa and 74 bb arethen adjusted, as described hereinabove. Each chord 74 aa and 74 bb maybe adjusted sequentially or simultaneously.

FIG. 13 shows chords 74 aa and 74 bb following their adjustment. Therelative dispositions of leaflets 12 and 14 are adjusted in conjunctionwith the adjusting of chords 74 aa and 74 bb. Typically, leaflets 12 and14 are drawn together.

As shown in FIG. 15, a third spool assembly may be coupled to dockingstation 56 c. Chord 74 c coupled thereto may be coupled to a thirdimplantation site in heart 2 and subsequently adjusted. FIG. 15 showsthird spool assembly 36 c coupled to docking station 56 c without thepresence of the other spool assemblies 36 a and 36 b, by way ofillustration and not limitation.

FIG. 16 shows a system 600 for repairing malpositioning of the wall ofthe ventricle of the patient, in accordance with respective applicationsof the present invention. System 600 treats a weakened state in whichthe wall of the left ventricle is malpositioned and weakened. As aresult, leaflets 12 and 14 of mitral valve 8 are malpositioned and aredistanced from one another. Spool assembly 36 implanted at a firstportion 420 of heart tissue which faces and surrounds the left ventricleof heart 2. First implantation site 5 thus comprises first portion 420of heart tissue. It is to be noted that first implantation site 5 is atthe base of the papillary muscle by way of illustration and notlimitation, and that first implantation site 5 may be at a portion ofthe wall of the heart in a vicinity of the apex of the heart, or atpapillary muscle 4.

Spool assembly 36 is implanted via docking assembly 150 at site 5 in amanner as described hereinabove with reference. The free ends of chord74 are coupled to a second portion 422 of heart tissue which faces andsurrounds the left ventricle of heart 2. Second implantation site 7 thuscomprises second portion 422 of heart tissue, e.g., at the septum, byway of illustration and not limitation. The free ends of longitudinalchord 74 are coupled to the heart tissue using any suitable attachmentmeans 602, e.g., sutures, knotting, or tissue anchors such as helicalanchors. Spool 46 of adjustment mechanism 43 is rotated, as describedhereinabove, thereby pulling tight chord 74 and thereby reducing alength of chord 74 between first and second implantation sites 5 and 7.In response to the pulling of chord 74, first and second portions 420and 422 of the heart tissue are pulled toward one another, and a lengthof chord 74 is adjusted. Consequently, the dimensions of the heart wallare restored to physiological dimensions, and leaflets 12 and 14 aredrawn toward one another.

FIG. 17 shows a system 610 for adjusting both malpositioning of a heartwall of heart 2, and a relative disposition of leaflet 12, in accordancewith some applications of the present invention.Multiple-docking-station assembly 350 is implanted at implantation site5, i.e., a portion of tissue of a heart wall of heart 2 in a vicinity ofthe apex of heart 2. It is to be noted that implantation site 5 mayinclude any portion of tissue of heart 2, e.g., a portion of tissue atthe base of papillary muscle 4, a portion of tissue of papillary muscle4, or a portion of the free wall of the ventricle. As describedhereinabove, first spool assembly 36 a is coupled to docking station 56a and adjusts a length of chord 74 aa in order to adjust a distancebetween implantation sites 5 and 7. Second spool assembly 36 b iscoupled to docking station 56 b and adjusts a length of chord 74 bb inorder to adjust a distance between implantation site 5 a thirdimplantation site 9 (e.g., leaflet 12, as shown). As describedhereinabove, chords 74 aa and 74 bb may be adjusted simultaneously orsequentially. Following the adjusting implantation sites 7 and 9 aredrawn toward multiple-docking-station assembly 350 at implantation site5. Consequently, the dimensions of the heart wall are restored tophysiological dimensions, and leaflets 12 and 14 are drawn toward oneanother.

FIG. 18 is a schematic illustration of a system 800 for adjusting adistance between two portions of a heart wall of the left ventricle ofthe patient, in accordance with some applications of the presentinvention. System 800 comprises a tensioning device 802 coupled at afirst end thereof to spool assembly 36 at docking assembly 150. In amanner as described hereinabove, spool assembly 36 is implanted at firstimplantation site 5 in a first portion of tissue of the heart wall thatfaces and surrounds the ventricular lumen. The free end of tensioningdevice 802 is attached at second implantation site 7 to a second portionof tissue of the heart wall that faces and surrounds the ventricularlumen. The free end of tensioning device 802 is implanted in hearttissue using a helical anchor by way of illustration and not limitation.For example, the free end of tensioning device 802 may be coupled tosecond implantation site 7 using sutures, knots, or any tissue anchorknown in the art.

Tensioning device 802 comprises a flexible material, e.g., ePTFE ornitinol, and is shaped to define a coiled portion 806 that has a lengthof between 20 mm and 50 mm and a diameter of between 0.5 mm and 3.0 mm.Tensioning device 802 comprises wire/suture portions 804 on either sideof coiled portion 806.

As described hereinabove, spool 46 of adjustment mechanism 43 is rotatedin order to adjust a distance between first and second implantationsites 5 and 7. As spool 46 is rotated in a first direction thereof,suture portion 804 that is disposed adjacently to spool assembly 36 iswrapped around spool 46. Tensioning device 802 is tightened andshortened in response to the wrapping of portion 804 around spool 46. Asdevice 802 is tightened, a force is applied to coiled portion 806 oftensioning device 802. Coiled portion 806 applies a supplemental pulingforce to help pull the opposing first and second portions of theventricle wall toward one another. Consequently, the dimensions of theheart wall are restored to physiological dimensions, and leaflets 12 and14 are drawn toward one another.

Reference is made to FIGS. 16-18. It is to be noted that the scope ofthe present invention includes the use of systems 600, 610, and 800 foradjusting a distance between any two portions of the heart and not justopposing portions, as described hereinabove. For example, first andsecond implantation sites 5 and 7 may be on the same side, e.g., theseptum, of the wall of the heart.

Reference is now made to FIG. 19 which is a schematic illustration of asystem 960 for drawing together leaflets 12 and 14 of mitral valve 8 ofthe patient, in accordance with some applications of the presentinvention. Spool assembly 36 is implanted via docking assembly 150 infirst implantation site 5 at papillary muscle 4 of the left ventricle byway of illustration and not limitation. For example, spool assembly 36may be implanted in a portion of the heart wall of the ventricle, e.g.,the base of the papillary muscle. First and second portions 74 a and 74b of chord 74 are coupled, e.g., sutured, anchored, clipped, locked inplace with a crimping bead 918, to leaflet 12 at an implantation site902. It is to be noted that portions 74 a and 74 b may be coupled toleaflets 12 and 14, respectively, using leaflet-engaging elements 72 asdescribed hereinabove.

As described hereinabove, spool 46 of adjustment mechanism 43 is rotatedin order to adjust a length of portions 74 a and 74 b of chord 74.Portions 74 a and 74 b are pulled tight in response to rotation of spool46 in a first direction thereof. In response to the pulling of portions74 a and 74 b, leaflets 12 and 14 are pulled toward one another in orderto restore coaptation to valve 8.

It is to be noted that system 960 may be used on the tricuspid valve.

System 960 further comprises at least one bead 940 that is threaded overportions 74 a and 74 b of chord 74. The surgeon adjusts the position ofthe bead along the portions 74 a and 74 b in order to set the degree towhich portions 74 a and 74 b are free to move with respect to oneanother. In general, as the bead is positioned closer to the valve, theportions 74 a and 74 b are more constrained in their motion with respectto one another, and the leaflets are drawn closer together. For someapplications of the present invention, the bead comprises a fixationmechanism (e.g., a crimping mechanism), which is configured to fix thebead to the longitudinal members once the bead has been positioned at adesire location along the members.

FIG. 20 shows a system 980 that is similar to system 960 as describedwith reference to FIG. 19, with the exception that bead 940 is pulled bythe operating physician to the ventricular surface of a middle portionof valve 8, in accordance with some applications of the presentinvention. Such pulling of bead 940 to the ventricular surface creates abridge between leaflets 12 and 14, e.g., as an Alfieri stitch, oredge-to-edge repair. Portions 74 a and 74 b are then adjusted in orderto pull together the middle portion of mitral valve 8, as shown inSection A-A. The firm coupling of leaflets 12 and 14 prevents prolapsingof leaflets 12 and 14, facilitates coaptation of leaflets 12 and 14, andcreates orifices 962 and 964 in mitral valve 8 so as to facilitate bloodflow from the atrium to the ventricle. Additionally, the adjusting ofportions 74 a and 74 b of chord 74 draws downward leaflets 12 and 14 andadjusts chord 74 such that it functions as an artificial chordeatendinea.

Reference is now made to FIGS. 19 and 20. It is to be noted thatalthough docking assembly 150 is shown, multiple-docking-stationassembly 350 as described hereinabove, may be implanted at implantationsite 5. For such an application, two or more spool assemblies 36 may becoupled to multiple-docking-station assembly 350, and any number ofchords 74 extending from each spool assembly 36 may be coupled toleaflets 12 and 14 at any suitable location thereof. The lengths ofchords 74 are then adjusted by spool assemblies 36 in order to pullleaflets 12 and 14 together.

For some applications of the present invention, systems 20, 220, 320,600, 610, 800, 960, and 980 are used to treat an atrioventricular valveother than the mitral valve, i.e., the tricuspid valve. For theseapplications, systems 20, 220, 320, 600, 610, 800, 960, and 980described hereinabove as being placed in the left ventricle are insteadplaced in the right ventricle.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section of the present patent application.

Additionally, the scope of the present invention includes applicationsdescribed in the following applications, which are incorporated hereinby reference. In an application, techniques and apparatus described inone or more of the following applications are combined with techniquesand apparatus described herein:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed on Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as US Patent Application Publication        2008/0262609;    -   U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec. 22, 2008;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009;    -   PCT Publication WO 10/004,546 to Gross et al., entitled,        “Annuloplasty devices and methods of delivery therefor,” filed        on Jun. 15, 2009;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed on Oct.        29, 2009;    -   U.S. Provisional Patent Application 61/265,936 to Miller et al.,        entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed Dec. 2, 2009;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009;    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010;    -   U.S. patent Ser. No. 12/689,693 to Hammer et al., entitled,        “Application Deployment techniques for annuloplasty ring,” filed        on Jan. 19, 2010;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2010;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010;    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed on May 4, 2010; and/or    -   U.S. Regular application Ser. No. 12/785,717 to Miller et al.,        entitled, “Adjustable artificial chordeae tendineae with suture        loops,” filed on May 24, 2010.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. Apparatus for use with at least one tissue-adjustment device,comprising: a tissue-engaging element having a distal portion configuredto engage at least a first portion of tissue of a patient, and having aproximal portion; at least one docking station coupled to the proximalportion of the tissue-engaging element, the at least one dockingstation: being configured to be coupled to the at least onetissue-adjustment device, and comprising a locking mechanism configuredto lock the tissue-adjustment device to the tissue-engaging element; andat least one guide member reversibly coupled to the at least one dockingstation, the at least one guide member being configured for facilitatingslidable advancement of the at least one tissue-adjustment device towardthe tissue-engaging element.
 2. The apparatus according to claim 1,wherein the guide member is looped around a portion of the dockingstation.
 3. The apparatus according to claim 1, wherein the at least onedocking station comprises two or more docking stations, and wherein theat least one guide member comprises two or more guide members, eachguide member being reversibly coupled to a respective docking station.4. The apparatus according to claim 1, further comprising thetissue-adjustment device, wherein the tissue-adjustment device has: anupper surface and a lower surface, at least one first opening at theupper surface, at least one second opening at the lower surface, and achannel extending between the first and second opening, the channelfacilitating advancement of the tissue-adjustment device along the guidemember.
 5. The apparatus according to claim 4, wherein thetissue-adjustment device comprises a first coupling, and wherein thelocking mechanism comprises a second coupling configured to be coupledto the first coupling.
 6. The apparatus according to claim 5, whereinthe second coupling comprises at least one depressed portion, andwherein the first coupling comprises at least one moveable baffle whichis configured to engage the at least one depressed portion of the secondcoupling.
 7. The apparatus according to claim 1, further comprising atleast one flexible longitudinal member coupled at a first portionthereof to the tissue-adjustment device, wherein a second portion of theflexible longitudinal member is configured to be coupled to a secondportion of tissue of the patient, and wherein the tissue-adjustmentdevice is configured to adjust a length of the longitudinal memberbetween the first and second portions of tissue.
 8. The apparatusaccording to claim 7, wherein: the first portion of tissue includes afirst portion of cardiac tissue at a first intraventricular site, thesecond portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and the flexible longitudinalmember comprises at least one artificial chordea tendinea.
 9. Theapparatus according to claim 7, wherein: the tissue-adjustment devicecomprises a rotatable structure, the at least one flexible longitudinalmember is coupled at the first portion to the rotatable structure, andthe rotatable structure is bidirectionally rotatable to adjust thedegree of tension of the flexible longitudinal member.
 10. The apparatusaccording to claim 9, wherein during rotation of the rotatable structurein a first rotational direction, successive portions of the flexiblelongitudinal member advance in a first advancement direction withrespect to the rotatable structure and contact the rotatable structure,to pull the second portion of the flexible member toward thetissue-adjustment device, and to draw the first and second portions oftissue toward each other.
 11. The apparatus according to claim 9,further comprising a rotatable structure locking mechanism displaceablewith respect to the rotatable structure, so as to: release the rotatablestructure during rotation of the rotatable structure, and lock in placethe rotatable structure following rotation of the rotatable structure.12. The apparatus according to claim 9, wherein the rotatable structurecomprises a spool, and wherein the at least one flexible longitudinalmember is configured to be wound around the spool during the rotation ofthe spool in a first rotational direction thereof.
 13. The apparatusaccording to claim 12, wherein the first portion of the flexiblelongitudinal member is looped through a portion of the spool.
 14. Theapparatus according to claim 13, wherein the first portion of theflexible longitudinal member is wound around a portion of the spool, andwherein the first portion of the flexible longitudinal member isconfigured to be unwound from around the portion of the spool followingthe coupling of the second portion of the flexible longitudinal memberto the second portion of tissue of the patient.
 15. Apparatus,comprising: a tissue-engaging element having a distal portion configuredto engage at least a first portion of tissue of a patient, and having aproximal portion; at least one docking station coupled to the proximalportion of the tissue-engaging element; a tissue-adjustment devicecouplable to the at least one docking station, the tissue-adjustmentdevice comprising: a rotatable structure; and at least one flexiblelongitudinal member having a first portion thereof that is in contactwith the rotatable structure, and a second portion thereof that isconfigured to be coupled to a second portion of tissue of the patient,wherein in during rotation of the rotatable structure in a firstrotational direction, successive portions of the flexible longitudinalmember advance in a first advancement direction with respect to therotatable structure and contact the rotatable structure, and, pull thesecond portion of the flexible longitudinal member toward thetissue-adjustment device, and responsively, to draw the first and secondportions of tissue toward each other; and at least one guide memberreversibly coupled to the at least one docking station, the at least oneguide member being configured for facilitating slidable advancement ofthe at least one tissue-adjustment device toward the tissue-engagingelement.
 16. The apparatus according to claim 15, wherein the guidemember is looped around a portion of the docking station.
 17. Theapparatus according to claim 15, wherein the at least one dockingstation comprises two or more docking stations, and wherein the at leastone guide member comprises two or more guide members, each guide memberbeing reversibly coupled to a respective docking station.
 18. Theapparatus according to claim 15, wherein the tissue-adjustment devicehas: an upper surface and a lower surface, at least one first opening atthe upper surface, at least one second opening at the lower surface, anda channel extending between the first and second opening, the channelfacilitating advancement of the tissue-adjustment device along the guidemember.
 19. The apparatus according to claim 18, wherein thetissue-adjustment device comprises a first coupling, and wherein thedocking station comprises a second coupling configured to be coupled tothe first coupling.
 20. The apparatus according to claim 19, wherein thesecond coupling comprises at least one depressed portion, and whereinthe first coupling comprises at least one moveable baffle which isconfigured to engage the at least one depressed portion of the secondcoupling.
 21. The apparatus according to claim 19, wherein the secondcoupling comprises a locking mechanism configured to lock thetissue-adjustment device to the tissue-engaging element.
 22. Theapparatus according to claim 15, wherein: the first portion of tissueincludes a first portion of cardiac tissue at a first intraventricularsite, the second portion of tissue includes at least one leaflet of anatrioventricular valve of the patient, and the flexible longitudinalmember comprises at least one artificial chordea tendinea.
 23. Theapparatus according to claim 15, wherein the rotatable structure isrotatable in a first rotational direction to apply tension to theflexible longitudinal member, and in a second rotational direction thatis opposite the first rotational direction to slacken the flexiblelongitudinal member.
 24. The apparatus according to claim 23, whereinduring rotation of the rotatable structure in a first rotationaldirection thereof, successive portions of the flexible longitudinalmember advance in a first advancement direction with respect to therotatable structure and contact the rotatable structure, responsively,to pull the second portion of the flexible longitudinal member towardthe tissue-adjustment device.
 25. The apparatus according to claim 23,further comprising a rotatable structure locking mechanism, displaceablewith respect to the rotatable structure so as to: release the rotatablestructure during rotation of the rotatable structure, and lock in placethe rotatable structure following rotation of the rotatable structure.26. The apparatus according to claim 23, wherein the rotatable structurecomprises a spool, and wherein the at least one flexible longitudinalmember is configured to be wound around the spool during the rotation ofthe spool in the first rotational direction thereof.
 27. The apparatusaccording to claim 26, wherein the first portion of the flexiblelongitudinal member is looped through a portion of the spool.
 28. Theapparatus according to claim 27, wherein the first portion of theflexible longitudinal member is wound around a portion of the spool, andwherein the first portion of the flexible longitudinal member isconfigured to be unwound from around the portion of the spool followingthe coupling of the second portion of the flexible longitudinal memberto the second portion of tissue of the patient.